FDA classifies Medtronic's ventilator correction a Class I recall

The software update addresses user interface problems that led Australian regulators to suspend the device.

By Nick Paul Taylor • Dec. 5, 2018

OIG finds Medicare overpaid $34M to device suppliers over three years

The overpayment stems from improper billing for prosthetics and other devices used at inpatient facilities.

By Nick Paul Taylor • Dec. 5, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Medicare could overpay billions for lab tests: GAO

Medicare's new method of calculating payment rates for laboratory tests was intended to save the government money but could instead end up costing CMS as much as $10.3 billion over three years.

By Susan Kelly • Dec. 3, 2018

The MedTech Dive Awards of 2018

The awards recognize the industry's top disruptors and newsmakers. These officials and companies are shaking up the medical technology sector and shaping the future.

By MedTech Dive Team • Dec. 3, 2018

Person of the Year: Bakul Patel, FDA

The regulator has drawn praise from Commissioner Scott Gottlieb and others for his Software Pre-Cert Program work.

By David Lim • Dec. 3, 2018

FDA's De Novo pathway is about to get a makeover

"Particularly with really low risk devices, it can be challenging both from FDA's perspective and industry's perspective in terms of how much data is needed," Allyson Mullen, an attorney at Hyman, Phelps & McNamara told MedTech Dive.

By Meg Bryant • Dec. 3, 2018

Disruption of the Year: EU regulatory overhaul

It’s a "pendulum swing," said Rajesh Misra, principal in KPMG's technology enablement practice. "More and more as we talk to clients, this is coming across as a bigger transformation than they originally thought … impacting [their] entire life cycle."

By Meg Bryant • Dec. 3, 2018

UK and EU inch toward regulatory cooperation after Brexit

As the leave date looms next March, a political declaration notes the bloc will explore the possibility of cooperation by U.K. authorities with agencies like the European Medicines Agency.

By Suzanne Elvidge • Dec. 3, 2018

FDA offers more study options for CLIA waivers in redrafted guidances

The agency added new test design alternatives for manufacturers seeking waivers for IVD devices, a nod to a push from AdvaMed and others.

By Maria Rachal • Nov. 30, 2018

FDA issues draft guidance on blood glucose monitors

The agency said distinguishing between test systems used in healthcare settings and those for use by patients at home will improve product safety and effectiveness of the devices.

By Susan Kelly • Nov. 30, 2018

Canada vows to strengthen device regulation following media probe

More stringent approval requirements and the mandatory publication of clinical data are among the changes being discussed.

By Nick Paul Taylor • Nov. 30, 2018

HHS outlines broad plan to reduce EHR burden

The 74-page draft strategy, required by the 21st Century Cures Act, focuses on reducing time and effort tied to regulatory reporting requirements and increasing functionality and user-friendliness of EHRs.

By Meg Bryant • Nov. 29, 2018

Why political contributions linked to a little-known hearing aid firm topped medtech giants

Spending connected to Starkey Hearing Technologies surpassed Medtronic, Boston Scientific and Edwards Lifesciences during the 2018 election cycle.

By David Lim • Nov. 29, 2018

5 takeaways amid new scrutiny of FDA medical device oversight

A slate of recent agency actions have paralleled a new investigative series on product safety by the International Consortium of Investigative Journalists. Here are five areas that could be impacted.

By David Lim • Nov. 27, 2018

FDA approves autoinjector version of Genentech's Actemra

The Roche unit is pitching the device as a convenient self-administration option for some users of its blockbuster drug.

By Nick Paul Taylor • Nov. 27, 2018

FDA pitches boosting 510(k) scrutiny, asks Congress for help

The agency wants to move away from device maker reliance on 510(k) predicate devices older than 10 years and gain new authority to quickly impose special controls.

By David Lim • Nov. 26, 2018

Beckman initiates Class I recall of flow cytometers

FDA is concerned inaccurate results provided by the devices could lead to serious injuries or deaths.

By Nick Paul Taylor • Nov. 22, 2018

FDA device inspections hit high amid overseas oversight push

The agency conducted 2,952 inspections of medical device manufacturers last year, an increase of 46% over 2007.

By Nick Paul Taylor • Nov. 22, 2018

ECRI launches clinical guidelines site to replace resource HHS shuttered

The new portal will include "expertly vetted, evidence-based guideline briefs and scorecards" for the healthcare community, according to the Pennsylvania-based nonprofit group.

By Rebecca Pifer Parduhn • Nov. 21, 2018

FDA details ramp-up of postmarket device oversight

The agency laid out plans to increase postmarket surveillance of medical devices and previewed details coming next week on how it expects to modernize premarket reviews, especially the 510(k) process.

By Susan Kelly • Nov. 21, 2018

Telehealth laws inhibit widespread use in Medicare population, CMS says

The agency is taking steps to open up virtual care options in some alternative payment models, but use among fee-for-service beneficiaries is only 0.25%, according to a new report.

By Meg Bryant • Nov. 19, 2018

Abbott seeks clearer security standards as feds increase cyber risk focus

President Trump is expected to sign legislation Friday creating a new cyber agency within the Department of Homeland Security. 

By Maria Rachal • Nov. 16, 2018

CMS' Verma outlines vision for connected digital health network

The agency also submitted a report to Congress on the state of Medicare telehealth, outlining how beneficiaries are currently using remote care and how CMS is looking to further expand similar services to rural areas.

By Nick Paul Taylor • Nov. 16, 2018

House chairman sees 'every indication' that VA's EHR difficulties will continue

"Frankly," Indiana Rep. Jim Banks said, "the more I learn about the EHR program, the more daunting it has become." 

By Tony Abraham • Nov. 15, 2018

AdvaMed makes lame duck push for medical device tax repeal

Given the impending Democratic control of the House, the trade group's CEO Scott Whitaker said "the chances are not as great next year" for permanent repeal if the industry does not garner a victory.

By David Lim • Nov. 15, 2018